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De-escalated Radiation for HPV-Positive Oropharynx Cancer After Surgery

This study is for people with newly diagnosed oropharynx cancer that is linked to human papilloma virus (HPV) and can be removed by surgery through the mouth. After surgery, your doctors will look at your tumor's characteristics to decide if you are low, intermediate, or high risk. Low-risk patients will not receive further treatment. Intermediate-risk patients will receive Intensity Modulated Radiotherapy (IMRT), a type of radiation. High-risk patients will receive IMRT along with chemotherapy (Cisplatin or Carboplatin). The main goal is to see how long people live without their cancer coming back (recurrence-free survival) for up to two years.

Study design
This is an interventional study planning to enroll 150 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo transoral surgery, and potentially receive radiation (IMRT) and/or chemotherapy (Cisplatin or Carboplatin) based on your risk level. You will be followed for up to five years after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years after the completion of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05388773

Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Heath Skinner
~150 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:therapeutic conventional surgerylaboratory biomarker analysisquality-of-life assessmentintensity-modulated radiation therapyCisplatinCarboplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-Free Survival (RFS)
Measured over Up to 2 years (for cohort)

Conditions

Oropharynx Cancer

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NCT05388773

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Heath Skinner, MD, PhD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Brieana Marino, MS
[email protected]
412-647-8258
Email the study team

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Eligibility criteria

Inclusion

ECOG performance status of 0 or 1 or Karnofsky score 80-100.
Preference is to register patients prior to surgery. However, if not registered prior to surgery, the patient can be registered prior to adjuvant therapy.
Patients must have newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx. Patients must have been determined to have resectable oropharyngeal disease. Patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible.
Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies. Metastatic disease may be evaluated using CT or PET/CT where appropriate; this can be performed with or without contrast. The following imaging is acceptable to evaluate the primary and regional disease:
CT Neck (with contrast preferred but not required)
PET/CT
MRI Neck (contrast preferred but not required)
Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node.
Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory. Using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended.
No prior radiation above the clavicles.
Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non- melanomatous skin cancer.
Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist prior to entry into the study.
Congestive heart failure \> NYHA Class II
CVA/TIA
Unstable angina
Myocardial infarction (with or without ST elevation)
Patients must have acceptable renal and hepatic function within 4 weeks prior to registration
In patients with a contraindication to cisplatin, carboplatin can be used at time of patient enrollment if they are allocated to ARM CRT.

Exclusion

No evidence of extensive or "matted/fixed" pathologic adenopathy on preoperative imaging.
Patients must not need a microvascular (free flap) reconstruction. Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Patient must not have an intercurrent illness likely to interfere with protocol therapy or prevent surgical resection
Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled hypertension within 30 days prior to registration.

What this trial measures

  • Recurrence-Free Survival (RFS)Up to 2 years (for cohort)

    Time to recurrence, defined as local and/or regional progression (identification of disease growth that is present within the area in which it was first located) and/or distant metastasis (identification of disease growth that is present in area(s) distant to that previously located). Local progression is defined as progression at the primary tumor site. Regional progression is defined as progression in the draining lymphatics (typically the cervical, retropharyngeal/retrostyloid and supraclavicular lymph nodes). Distant progression is defined as tumor recurrence in one or more non-local and non-regional sites (e.g., bone, lung, liver, etc.). Recurrent malignancy will be determined based on clinical exam and imaging findings. Patients who are disease-free but who die from other causes will be censored.